Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery

ISRCTN	ISRCTN49212975
DOI	https://doi.org/10.1186/ISRCTN49212975
Protocol serial number	HTA 11/106/01
Sponsor	North Bristol NHS Trust (UK)
Funder	NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/106/01

Submission date: 19/07/2013
Registration date: 22/07/2013
Last edited: 17/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-trial-comparing-devices-help-men-urine-leakage-after-prostate-cancer-surgery-master

Contact information

Prof Paul Abrams
Scientific

Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Email	paul.abrams@bui.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled non-inferiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial (MASTER)
Study acronym	MASTER
Study objectives	The trial will investigate whether a male synthetic sling is non-inferior to implantation of an artificial urinary sphincter (AUS) for men who have urinary incontinence after prostate surgery (for cancer or benign disease). More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1110601
Ethics approval(s)	Currently being reviewed by National Research Ethics Service (NRES) Committee South West - Frenchay
Health condition(s) or problem(s) studied	Adult men with urodynamic stress incontinence after prostate surgery
Intervention	Two surgical operations for male urinary incontinence, a synthetic male sling and an artificial urinary sphincter (AUS) implantation will be evaluated. All adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery and who consent to participate will be included in the study. If the treating urologist advises that either of the interventions are suitable for the patient and the man agrees to randomisation, he will be randomised to receive one of the two procedures. The patients who are not eligible for randomisation (if the urologist advises one particular type of surgery and/or the man is not willing to be randomised) will be invited to consent to be followed-up. All men, whether in the randomised controlled trial or who are being followed-up, will complete questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months after surgery. Randomised men only will attend a review appointment with their urologist at 12 months following surgery to evaluate the results of surgery, including a 24 hour pad test.
Intervention type	Other
Primary outcome measure(s)	1. Clinical effectiveness of implantation of the male sling compared with AUS in terms of self-reported incontinence at 12 months. 2. Cost effectiveness of a policy of primary implantation of the male sling compared with AUS, measured by incremental cost per quality-adjusted life-year (QALY) at 24 months.
Key secondary outcome measure(s)	1. Risks of each type of surgery 2. Costs of the benefits and risks of each treatment policy 3. Subsequent NHS services (including repeat surgery) needed for men with persistent or recurrent problems 4. The differential effects of the operations on other outcomes such as quality of life and general health 5. Satisfaction of the men with each procedure
Completion date	01/07/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	720
Total final enrolment	480
Key inclusion criteria	Adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery.
Key exclusion criteria	1. Men who have had previous male sling or AUS surgery. 2. Men with unresolved bladder neck contracture or urethral stricture after prostate surgery. 3. Men who do not consent to be randomised (these men will be asked to consent to follow up). 4. Men with insufficient manual dexterity to operate AUS device. 5. Men who are unable to give informed consent or complete trial documentation.
Date of first enrolment	29/01/2014
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bristol Urological Institute

Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2021	02/06/2021	Yes	No
Results article		01/08/2022	17/08/2022	Yes	No
Protocol article	protocol	21/02/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/08/2022: Publication reference added.
02/06/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/06/2020 to 01/07/2025.
2. Publication reference and total final enrolment added.
10/01/2020: The recruitment start date was changed from 01/07/2013 to 29/01/2014. The publication and dissemination plan and IPD sharing statement were added.
09/10/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 31/12/2017.
2. The overall trial end date was changed from 30/06/2019 to 01/06/2020.
3. Publication reference added.